The primary efficacy variable was the change from baseline in urine NTx (corrected by creatinine). The primary analysis time point was at 6 months of treatment. The results are reported as nanomoles (nM) of bone collagen equivalents (BCE) per millimole (mM) of urine creatinine.

Patients were asked to complete the satisfaction questionnaire at baseline. The questionnaire assessed overall satisfaction with the i.v. infusion procedure. The possible answers to the question were: "not at all," "a little," "somewhat," "quite," or "completely."

At the end-of-study visit, Month 6, patients were asked to complete a questionnaire to assess preference for the different treatment modalities (annual i.v. infusion vs. daily oral capsule). The possible answers to question were: "once a year i.v. infusion," "once daily pill," or "both are equal."

Females, between 45 and 80 years (inclusive) of age, considered post-menopausal according to one of the following guidelines:

Cessation of menses for 18 months in women < 50 years of age

Cessation of menses for 12 months in women age 50 years or over

Documented bilateral oophorectomy at least 1 year previously

Documented T score of less than or equal to -1.5 on dual energy X-ray absorptiometry (DXA) scan at the lumbar spine, total hip or femoral neck within 24 months prior to screening, and clinically indicated for treatment with bisphosphonates (BPs) for osteopenia or osteoporosis

Signed informed consent prior to initiation of any study procedure

Exclusion Criteria:

Prior treatment with i.v. bisphosphonates within the last 2 years

Previous use of oral bisphosphonates within the past 2 years (unless used for less than 8 weeks*).

*NOTE: If used less than 8 weeks, the washout period is 6 months.

Treatment with raloxifene, calcitonin, tibolone or hormone replacement therapy. The washout period for these medications is 6 months prior to randomization.

Any treatment with strontium renalate, sodium fluoride or parathyroid hormone

Use of systemic high dose corticosteroids at an average dose of ≥ 7.5 mg per day of oral prednisone or equivalent for a period of three months or more within the previous year

Treatment with any investigational drug within 30 days prior to randomization

Any woman of child bearing potential

Patients with fractures occurring within three months prior to randomization

History of hypersensitivity to bisphosphonates

History of non-traumatic uveitis or iritis, within 2 years prior to study entry.

A history of invasive malignancy of any organ system, treated or untreated, within the past 12 months prior to screening; excluding, basal cell or squamous cell carcinoma of the skin, colonic polyps with non-invasive malignancy which have been removed, Ductal Carcinoma in-situ (DCIS) that has been surgically removed, and Carcinoma in-situ (CIS) of the uterine cervix that has been surgically removed.

Previous major solid organ transplant recipient or on a transplant waiting list

History of hyperparathyroidism, hypoparathyroidism, Osteogenesis imperfecta, Paget's disease or any metabolic bone disease other than osteoporosis

Any medical condition which would interfere with the action of the study drug or limit life expectancy to less than 6 months

Any medical or psychiatric condition which, in the opinion of the investigator, would preclude the participant from adhering to the protocol or completing the trial

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00431444